FDA Blocks Imports Of Some Cochlear Hearing Aids

Law360, New York (February 22, 2008, 12:00 AM EST) -- Implantable hearing-aid maker Cochlear Limited has received a warning letter from the U.S. Food And Drug Administration that the agency has blocked the import of implants made by its Swedish subsidiary.

The Sydney, Australia-based company said Friday that the letter was sent to its Swedish unit Cochlear Bone Anchored Solutions AB, advising the company that the FDA had issued an import alert blocking Cochlear's Baha products from Sweden from entering the U.S.

“Cochlear is committed to full compliance with the FDA regulations and will work with...